Advantages and risks of using CDK4/6 inhibitors, including palbociclib, in first-line therapy for HR+ metastatic breast cancer
Summary. Breast cancer (BC) is the most common oncological disease in women and a leading cause of mortality, with hormone receptor-positive (HR+) BC being one of the most prevalent subtypes. Endocrine therapy (ET), particularly with aromatase inhibitors (AIs), is the standard treatment for HR+ BC, but its effectiveness is limited by the development of resistance. Cyclin-dependent kinase (CDK) 4/6 inhibitors, such as palbociclib, have significantly expanded the treatment options for HR+ BC by halting the tumor cell cycle at the G1 phase. Palbociclib, in combination with AIs or fulvestrant, demonstrates substantial improvement in progression-free survival (PFS), outperforming ET monotherapy in postmenopausal and premenopausal women. However, combined therapy is associated with an increased risk of toxicity, particularly grade III–VI neutropenia, necessitating careful monitoring and dose adjustments. The PALOMA trials confirm the efficacy of palbociclib for various patient groups with HR+/HER2− metastatic BC, and its use is recommended in international clinical guidelines (National Comprehensive Cancer Network (NCCN), European Society for Medical Oncology (ESMO), American Society of Clinical Oncology (ASCO)). Palbociclib in first-line therapy is an effective choice for long-term disease control, improved quality of life, and management of endocrine resistance. At the same time, a personalized approach to therapy is essential to ensure a balance between clinical efficacy and treatment safety.
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